Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine

Beijing Tiantan Hospital200 enrolled

Overview

This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM.

Chronic migraine (CM) is a disabling disease that causes serious physical and emotional consequences. Previous studies had suggested the efficacy of stellate ganglion block (SGB) with lidocaine in the treatment of CM. However, the side effects related to repeated procedures limit its applications. Platelet-rich plasma (PRP) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. So far, there has not been any report on PRP combined with lidocaine acting on SGB for CM. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined PRP acting on SGB versus lidocaine alone acting on SGB in patients with CM

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Platelet-rich Plasma Chronic Migraine

Interventions

No interventionsOTHER

It is a observational study

Not have interventionsOTHER

It is a observational study

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 to 75 years; 2. BMI between 15 and 35 kg/m2 ; 3. Diagnosed with CM in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria (Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211); 4. Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥4; 5. Scheduled for lidocaine acting on SGB treatment for CM； 6. Signed informed consent. Exclusion Criteria: 1. Previously received SGB treatment; 2. Combined with other types of headaches; 3. Platelet count \<105\*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders; 4. Infection or mass near the puncture site; 5. A history of other neurological disorders; 6. A history of severe cardiopulmonary, hepatic or renal dysfunction; 7. A history of psychological disorders; 8. A history of narcotic drug abuse; 9. Changes in neck anatomic structure caused by radiotherapy or surgery; 10. A history of allergies to any research drugs; 11. Pregnancy or lactation period.

Locations (1)

Fang Luo

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

the change from baseline in mean headache days across the 1-month follow-up period.

Time frame: 1-month period

Secondary Outcomes

50% responder rate

the proportion of patients who achieved a ≥50% reduction in monthly headache days.

Time frame: at weeks 4, 8, 12.

Mean VAS score during headache attack

evaluation of the average severity of headache days

Time frame: at baseline and weeks 4, 8, 12.

Analgesic consumption

including the number of days, the specific drug used, and the dose of drugs.

Time frame: at baseline and weeks 4, 8, 12.

Patient satisfaction (PS) scores

It ranges from 0 to 10 points, and 0 indicates unsatisfactory, while 10 points indicate very satisfactory.A higher scores mean a better satisfaction

Time frame: at weeks 4, 8, 12.

Headache impact test version 6 (HIT-6)

a six-item survey that assesses the adverse impact of headaches on social, role and cognitive functioning, vitality, and psychological distress.A larger score reflects a greater adverse impact. It ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent

Time frame: at baseline and weeks 4, 8,12.

Migraine disability assessment (MIDAS) scores

to evaluate headache-related disability using 4-week recall, and is associated with headache frequency and average pain score.The score ranges from 0 to 270. Higher scores indicate greater disability caused by headaches with scores of 21 or greater considered severe.

Data from ClinicalTrials.gov

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